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FDA Issues Proposed Rules to Implement FSMA Produce Safety Standards and Preventive Controls

Date: Jan 17, 2013

On January 4, 2013, FDA issued two long-awaited proposed rules to implement the produce safety and hazard analysis and risk-based preventive control (HARPC) provisions of the FDA Food Safety Modernization Act (FSMA).[1] FDA has also prepared summary "fact sheets" that outline the general requirements of the produce safety and the HARPC proposed rules. Below, we provide the "highlights" of each proposal.

Highlights of the Proposed Rule to Implement Produce Safety Standards

FDA proposed the produce safety rule to implement Section 419 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The proposed rule establishes science-based minimum standards to ensure the safe growing, harvesting, packing, and holding of raw fruits and vegetables, including some commodities not traditionally perceived as fruits and vegetables, e.g., mushrooms, tree nuts, and herbs. The produce safety standards are intended to address only microbiological contamination, and the bulk of the proposed rule addresses the following prevalent sources of such contamination on farms:

  • "agricultural water";[2]
  • personnel qualifications, training, health and hygiene;
  • biological soil amendments of animal origin;
  • domesticated and wild animals in the growing area; and
  • equipment, tools, buildings, and sanitation.

The only commodity-specific standards that appear in the proposed rule apply to sprouts.

Unless excluded, a food that is: (1) produce; (2) a raw agricultural commodity (RAC); and (3) intended for human consumption is subject to the proposed rule. The proposed rule excludes the following types of produce from its scope: (1) produce that is rarely consumed raw;[3] (2) produce that is produced for personal or on-farm consumption; and (3) produce that is not a RAC, e.g., fresh-cut produce. Also, covered produce is eligible for an exemption when it receives commercial processing that adequately reduces the presence of microorganisms of public health significance ("kill step" processing).

The proposed rule applies to "covered farms," although some farms may be eligible for a qualified exemption based on the volume of their food sales in the prior three years and based on the amount of their sales to qualified end-users (i.e., local purchasers). FDA may withdraw a qualified exemption on the basis of safety concerns associated with the farm.

The produce safety regulations would be effective 60 days after the publication of the final rule. FDA is proposing extended compliance timeframes that range from two to four years after publication of the final rule, based on the size of the farm.

Highlights of the Proposed Rule to Implement HARPC Requirements

FDA proposed the HARPC rule to implement Section 418 of the FD&C Act. The proposed rule is intended to: (1) clarify the definition of a "farm" for purposes of FDA's facility registration requirement at Section 415 of the FD&C Act; (2) expand, revise, and reorganize FDA's current Good Manufacturing Practice (cGMP) regulations; and (3) describe the HARPC requirements applicable to covered food facilities under Section 418 of the FD&C Act. The HARPC framework is intended to address biological, chemical, physical, or radiological agents reasonably likely to cause illness or injury in the absence of their control.

The core HARPC requirement involves the creation of a written food safety plan that must include:

  • a hazard analysis;
  • preventive controls;
  • monitoring procedures;
  • corrective action procedures;
  • verification procedures; and
  • a recall plan.

A "qualified individual" (whether qualified by training or experience) must prepare the written plan and must be involved in the validation of preventive controls, the review of records for implementation and effectiveness, and the reanalysis of the plan. Such qualified individual may be, but does not necessarily have to be, an employee of the food facility.

Most facilities subject to FDA's registration requirement at Section 415 of the FD&C Act are subject to the HARPC requirements, although exemptions are available for: (1) certain low-risk on-farm activities conducted by small or very small businesses; (2) foods subject to the low-acid canned food (LACF) regulation (although the exemption applies only to those microbiological hazards addressed by the LACF regulation); (3) foods subject to seafood HACCP regulations; (4) foods subject to juice HACCP regulations; (5) dietary supplements; (6) alcoholic beverages; (7) facilities subject to the produce safety standards at Section 419 of the FD&C Act; and (8) facilities, such as warehouses, that store RACs that are fruits or vegetables intended for further distribution or processing. Certain facilities are subject to modified HARPC requirements, namely: (1) facilities, such as warehouses, that only store packaged foods that are not exposed to the environment;[4] and (2) qualified facilities, which are very small businesses and other small businesses that sell primarily to qualified end-users (local purchasers). FDA may withdraw a qualified facility's exemption on the basis of safety concerns associated with the facility.

Although FDA does not actually include them in the proposed rule itself, the Agency requests comments on the following three specific controls and procedures: (1) product testing as a verification procedure; (2) environmental monitoring as a preventive control or verification procedure; and (3) supplier verification and approval. FDA also requests comments on whether facilities should be required to review complaints and to submit "facility profiles" to FDA on a periodic basis.

The HARPC regulations would be effective 60 days after the publication of the final rule. FDA is proposing extended compliance timeframes that range from one to three years after publication of the final rule, based on the size of the facility.

Keller and Heckman LLP has prepared more detailed summaries of both proposed rules. If you are interested in receiving copies of our summaries, or if you would like more information about the proposed rules and FSMA more generally, please contact Melvin S. Drozen (drozen@khlaw.com) (202-434-4222), Leslie T. Krasny (krasny@khlaw.com) (415-948-2810), Evangelia C. Pelonis (pelonis@khlaw.com) (202-434-4106) or Alissa D. Jijon (jijon@khlaw.com) (202-434-4109).



[1] FDA published the proposed rules on its website on January 4, 2013, and the proposed rules appeared in the Federal Register on January 16, 2013.

[2] Indirect water application methods would not be subject to this rule.

[3] The proposed rule includes an exhaustive list of specific fruits and vegetables that meet this definition.

[4] If the facility stores only packaged food for which refrigeration is not required for safety, such facility is exempt from the HARPC requirements. If the facility stores packaged food for which refrigeration is required for safety, modified preventive control requirements (addressing only temperature controls) apply.